LEO Pharma A/S

Industriparken 55 DK-2750 Ballerup, Denmark

+45 44 94 58 88 https://www.leo-pharma.com

Compounds:

• Spesolimab
  

  Spesolimab

  Managed Access Program for SPEVIGO™ (Spesolimab)

  The purpose of the spesolimab Managed Access Program (MAP) is to provide access to spesolimab for the treatment of selected immunoinflammatory dermatologic diseases mediated by Interleukin-36 (IL-36R) and/or neutrophil driven pathways.

  The MAP is open to requests for patients who may benefit from treatment with spesolimab including 1) patients who have previously received spesolimab treatment through Boehringer Ingelheim’s “out of scope” program; and 2) new patients not previously receiving spesolimab. For new patients, the requesting physician will provide a detailed case summary to Early Access Care (EAC). Once all requested information is received, LEO Pharma will review submitted documentation. The decision will be communicated to the requesting physician by EAC within one business day.

  The treating physician is the medical doctor who may be a specialist, dermatologist, immunologist or otherwise qualified physician (“Physician”) who takes full responsibility for the treatment of the individual patient, according to the local laws and regulations.

  What are the eligibility requirements for the program?

  Patients must be medically eligible to participate in the program. In addition, Health Authority approval must be obtained in the country where the patient will be treated and has been deemed eligible.

  Inclusion Criteria

  In order for a patient to be considered for treatment in the MAP the following inclusion criteria must be met:

  1. Diagnosis of a serious or potentially life-threatening immunoinflammatory dermatologic disease mediated by Interleukin-36 (IL-36R) and/or neutrophil driven pathways.
  2. No satisfactory approved alternative treatment options for the condition, and the patient is not eligible for an available clinical trial.
  3. Adults (≥18 years) and pediatric patients (<18 years of age)
  4. In the opinion and clinical judgement of the treating physician, potential benefit outweighs potential risk of receiving spesolimab therapy, based on the individual patient’s medical history and program eligibility criteria, and judged by the treating physician to be medically suitable for treatment with spesolimab.

  Exclusion Criteria

  Patients must not meet any of the following criteria:

  1. Active systemic, relevant chronic, recurrent or acute infections (eg, HIV infection or viral hepatitis) or ongoing antimicrobial therapy
  2. Spesolimab initiation is not recommended in patients with active TB infection; consider anti-TB therapy for patients with a history of or latent TB prior to spesolimab.
  3. History of allergy/hypersensitivity to systemically administered spesolimab or its excipients which may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS)

  How are requests for the MAP submitted?

  Beginning April 1, 2026 a patient’s treating physician may submit a request for managed access on their behalf by emailing spesolimab@earlyaccesscare.com. Alternatively, the physician may self-register in the portal by clicking here to make a request.

  The treating physician submits a request on behalf of their patient. No patient is guaranteed entry into the program solely by applying. Once medical eligibility is confirmed, health Authority approval must be obtained in the country where the patient will be treated and has been deemed eligible. Physicians must follow local laws and regulations appropriate for the country originating the request.

  How are requests evaluated?

  LEO Pharma commits to a careful and fair evaluation of each request. The physician will be required to provide adequate medical history and treatment information for a specific patient. All initial requests will be acknowledged by LEO Pharma or our representative within one business day. Requests will thereafter be reviewed using LEO Pharma's processes and standards.

  Physicians and Healthcare Professionals: Only appropriately licensed physicians may make a written request on behalf of a patient. The physician must be qualified to administer and oversee the investigational treatment and comply with LEO Pharma safety reporting responsibilities.

  Patients, Caregivers and Patient Advocates: Requests for MAP must be made by a qualified physician. LEO Pharma encourages patients and caregivers to have a candid conversation about reasons for considering an investigational medicine. Your physician will be required to supervise the treatment and comply with safety reporting responsibilities. Your physician must make the written request on your behalf.

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  Available in These Countries:

  • United States of America
  • France
  • Australia
  • Germany
  • Italy
  • Portugal
  • Spain
  • United Kingdom

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